A recent lawsuit by Horizon Blue Cross/Blue Shield of New Jersey has the potential to cripple point of care testing arrangements often employed by drug and alcohol treatment centers. At risk is not only the roughly $36 Million sought to be recouped by BC/BS, but also perhaps the many millions more which may be claimed by other payers as well.
BC/BS is making serious allegations against Avee Laboratories, Alere, Inc., and a number of recovery centers. The factual allegations include:
- Avee used false and deceptive marketing materials to get recovery centers to order medically unnecessary tests.
- They offered unlawful inducements to encourage healthcare providers to order POCT.
- 1. They provided medically unnecessary POCT.
- They provided medically unnecessary POCT.
- They referred their patients to Avee for unnecessary confirmatory testing.
The drug and alcohol treatment community is watching the case closely to see how it may impact (1) their involvement with POCT, and (2) their relationships with tox labs. Activities like the provision of free or reduced fee POCT cups and routine copay or deductible waivers are also mentioned in the suit as being suspect and illegal.
The drug and alcohol treatment community is not the only link in the chain for whom the suit is relevant. Many medical providers perform POCT, including physicians specializing in treating pain. And many of those providers have had communications with tox labs that sound remarkably similar to the ones described in the lawsuit.
The case is very instructive because imbedded in it are compliance related suggestions, some of which may not be apparent to many healthcare service providers, like:
- Confirmatory testing of negative POCT results requires the healthcare provider has documented clinical reasons to believe the negative POCT was inaccurate or inconclusive.
- Clinical labs must have a compliance program to detect and prevent healthcare providers from performing unnecessary POCT and ordering unnecessary confirmatory testing.
- A clinical lab may not offer below market value POCT tests and consulting agreements in order to induce healthcare providers to refer tests.
- Labs may not waive patient financial responsibility to induce healthcare providers to refer urine specimens to the lab.
It is probably common sense to expect that, with claims that amount to this dollar volume, payers are going to pay particular attention to toxicology labs. The suit is a “shot across the bow” of the POCT and tox lab industry. Compliance is king in these arrangements, and all healthcare providers need to look closely at regulatory compliance.